Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DNA Genotek, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
506 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254121 | Colli-Pee•Dx Urine Collection Kit | DNA Genotek, Inc. | 2026-06-10 | 173 | 0 |
| K212745 | ORAcollect®•Dx | DNA Genotek, Inc. | 2022-10-27 | 423 | 0 |
| DEN200040 | OMNIgene GUT Dx | DNA Genotek, Inc. | 2021-11-03 | 506 | 0 |
| K192920 | Oragene®•Dx | DNA Genotek, Inc. | 2020-01-14 | 90 | 0 |
| K152464 | ORAcollect.Dx | DNA Genotek, Inc. | 2016-05-26 | 269 | 0 |
| K152556 | Oragene Dx | DNA Genotek, Inc. | 2016-05-26 | 261 | 0 |
| K141410 | ORAGENE DX OGD-500.001 | DNA Genotek, Inc. | 2015-02-19 | 266 | 0 |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; | DNA Genotek, Inc. | 2011-12-02 | 263 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda